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NCT07132905: MYT

Mpata Yathu Trial for Young Women in Zambia

Not yet recruiting NA Last updated 20 August 2025
What this trial tests

NA trial testing Mpata Yathu ("Our Space") in HIV in 180 participants. Not yet recruiting.

Timeline
22 September 2025
Primary endpoint
30 June 2026
30 June 2026

Quick facts

Lead sponsorUniversity of California, San Francisco
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment180
Start date22 September 2025
Primary completion30 June 2026
Estimated completion30 June 2026
Sites1 location across Zambia

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Francisco

Who can join

Adults 15 to 24, female only, with HIV or Common Mental Health Problems. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to improve mental health and HIV-related outcomes among adolescent girls and young women (AGYW) in Zambia who have experienced gender-based violence (GBV). GBV includes physical, sexual, or emotional violence from partners or others and is known to increase the risk of depression, anxiety, post-traumatic stress, and HIV infection. In Zambia, access to mental health services is limited, especially for young women in low-resource communities. This study tests a counseling program called Mpata Yathu, which means "Our Space" in Chinyanja, designed to provide psychological support and improve well-being for young women who have faced violence and may be living with or at risk for HIV. Mpata Yathu is a culturally adapted version of the Friendship Bench, a lay counselor-delivered mental health intervention originally developed in Zimbabwe. In this adapted version, trained community lay counselors will deliver six individual problem-solving therapy (PST) sessions over a three-month period. Sessions will be delivered in private spaces within local Catholic churches in the Matero and Chawama areas of Lusaka, Zambia. Counseling sessions will also include referral options for participants who may need further support related to HIV care, GBV, or mental health concerns. The study is a two-arm randomized controlled trial. Participants will be randomly assigned to either: 1. Immediate Intervention Group - Receives the Mpata Yathu intervention between baseline and 3-month follow-up 2. Waitlist Control Group - Receives usual care for the first 3 months and then receives the Mpata Yathu intervention between 3- and 6-month follow-up A total of 180 young women (90 per group) will participate in the trial. To be eligible, participants must be between the ages of 15 and 24, reside in the Matero or Chawama area, report lifetime GBV exposure, and show moderate depressive symptoms or symptoms of common mental disorders (CMDs). They must also be living with HIV or report behaviors that place them at risk for HIV. The primary outcome is symptoms of CMDs, assessed using the Shona Symptom Questionnaire (SSQ-14). Secondary outcomes include depression, anxiety, and PTSD symptoms, as well as HIV-related outcomes such as clinic attendance, antiretroviral therapy (ART) adherence, and prevention behaviors such as condom use or PrEP readiness. The study will also measure feasibility, acceptability, and fidelity of the intervention. Data will be collected through surveys at baseline, 3 months, and 6 months. The research team will also monitor how the intervention is implemented, how participants respond to counseling, and whether counselors follow the therapy protocol. Participants will receive a small stipend for their time and transport at each counseling session and follow-up visit. This study is designed to test whether a trauma-informed, church-based mental health intervention can improve psychological well-being and HIV engagement among young women who are often underserved in traditional healthcare systems. If successful, this model could be expanded to other churches or schools in Zambia and similar settings. The results will inform future large-scale evaluations and could help shape new strategies for addressing GBV, mental health, and HIV among youth in sub-Saharan Africa.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Church-based problem-solving therapy for adolescent girls and young women with a history of gender-based violence in Zambia: study protocol for a hybrid type 1 randomized controlled trial.
    Ahmed CV, Thornicroft M, Chileshe K, Ntebeka BM, et al · · 2026 · PMID 41957660 · DOI 10.1186/s13063-026-09625-3

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